Device product
Boston Scientific Zurpaz(TM) MEDIUM CURL, SYMMETRIC CURVE, Steerable Sheath, 8.5F (2.83mm), REF Catalog No M004USMC85100
Z-2530-2017
Product summary
- Event
- Event 77406
- Status
- Terminated
- Classification
- Class II
- Quantity
- 150 units
- Official record key
device-enforcement:Z-2530-2017
Official wording
Reason: Lack of sterility assurance.
Code information: Lot # 383271, 384264
Distribution pattern: Distributed in MA.
Derived failure modes
-
Sterility assurance
Lack of sterility